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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05550207
Other study ID # AXS-07-304
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date August 31, 2022
Est. completion date December 2024

Study information

Verified date April 2024
Source Axsome Therapeutics, Inc.
Contact Study Director
Phone +1 (212) 332-5061
Email cstreicher@axsome.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multicenter, open-label trial to evaluate the efficacy and safety of AXS-07 in subjects with migraine attacks and prior inadequate response to oral CGRP inhibitors.


Description:

Eligible subjects will receive open-label AXS-07 for up to 8 weeks for at-home treatment of their next 4 migraine attacks.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Has an established diagnosis of migraine with or without aura - Has experienced an inadequate response to oral CGRP inhibitors for the acute treatment of migraine Exclusion Criteria: - Pregnant, breastfeeding, or planning to become pregnant during the study - Has previously received any investigational drug or device or investigational therapy within 30 days before Screening

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
AXS-07 (meloxicam-rizatriptan)
AXS-07 tablets, taken orally for the acute treatment of migraine

Locations

Country Name City State
United States Clinical Research Site Albuquerque New Mexico
United States Clinical Research Site Avon Indiana
United States Clinical Research Site Boston Massachusetts
United States Clinical Research Site Bronx New York
United States Clinical Research Site Charleston South Carolina
United States Clinical Research Site Charlottesville Virginia
United States Clinical Research Site Colton California
United States Clinical Research Site Coral Gables Florida
United States Clinical Research Site Cypress Texas
United States Clinical Research Site DeLand Florida
United States Clinical Research Site Fullerton California
United States Clinical Research Site Hallandale Beach Florida
United States Clinical Research Site High Point North Carolina
United States Clinical Research Site Knoxville Tennessee
United States Clinical Research Site La Jolla California
United States Clinical Research Site Las Vegas Nevada
United States Clinical Research Site Los Angeles California
United States Clinical Research Site McLean Virginia
United States Clinical Research Site Nashville Tennessee
United States Clinical Research Site North Dartmouth Massachusetts
United States Clinical Research Site Ormond Beach Florida
United States Clinical Research Site Oviedo Florida
United States Clinical Research Site Pensacola Florida
United States Clinical Research Site Philadelphia Pennsylvania
United States Clinical Research Site Salt Lake City Utah
United States Clinical Research Site Sherman Oaks California
United States Clinical Research Site Stamford Connecticut
United States Clinical Research Site Stockbridge Georgia
United States Clinical Research Site Sugar Land Texas
United States Clinical Research Site Sunrise Florida
United States Clinical Research Site Williamsville New York
United States Clinical Research Site Winter Park Florida

Sponsors (1)

Lead Sponsor Collaborator
Axsome Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of subjects with headache pain relief Absence of headache pain and without the use of rescue medication. Hour 2 following dose administration
Primary Percentage of subjects with absence of the Most Bothersome Symptom Absence of the most bothersome symptom, defined at the onset of migraine. Hour 2 following dose administration
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